VMRA-SAT is a structured, globally applicable, country-owned and voluntary self-assessment tool designed specifically for authorities responsible for regulating veterinary medicinal products. It helps authorities evaluate the maturity and implementation of their veterinary medicines regulatory systems through a self-led, evidence-based process, identify strengths and gaps, agree priorities and support institutional development planning.
VMRA-SAT was developed to address the specific need for a veterinary medicines regulatory system assessment tool. It complements existing WOAH support mechanisms and broader frameworks such as the PVS Pathway and Veterinary Legislation Support Programme by providing a detailed diagnostic focused on veterinary medicinal products.
VMRA-SAT helps authorities assess their veterinary medicines regulatory system, identify areas for improvement and develop clear, evidence-based plans for strengthening regulatory capacity over time.
Veterinary medicines regulation worldwide faces six interconnected challenges: antimicrobial resistance driven by uncontrolled antimicrobial use; substandard and falsified veterinary products circulating on the market; chronic shortages caused by fragmented registration pathways; inability to access vaccines and treatments quickly during emergencies; harmful residues in food of animal origin that threaten health and trade; and insufficient workforce capacity to regulate effectively. VMRA-SAT is designed to help countries assess and strengthen the regulatory systems that address these challenges.
Pilot feedback shows that the tool is valued for helping authorities identify practical improvement actions, support honest self-reflection and provide a clearer basis for planning future development. Users also saw value in the potential for benchmarking and shared learning in the future.
The tool can support regulatory system strengthening by helping authorities make sense of complex systems in a structured way. It can inform institutional development plans, support governance discussions, guide prioritisation and help authorities present a clearer case for reform and investment.
No. VMRA-SAT is a self-assessment tool. The process is led by the country itself, using its own staff, and the results remain entirely with the country. There is no external judgement, ranking or conditionality attached to the assessment. It is designed as a mirror for regulators, highlighting both strengths and gaps.
Yes. The available evidence suggests that VMRA-SAT is useful not only for reviewing the current situation, but also for shaping future action. Follow-up discussions and correspondence show that authorities use the outputs to identify realistic priorities, engage leadership and support institutional development planning.
Yes. A common assessment framework can help support benchmarking, cooperation and regulatory learning across authorities.
Some authorities may find a full self-assessment difficult if their systems are still at an early stage, or if staffing, resources, time or documentation are limited. In these contexts, the tool can still be useful as a reference point or checklist. In response to pilot feedback, a Lite Web Version (WebApp) has been created as a lighter and more accessible starting point.
The tool assesses eight core regulatory functions: national regulatory system governance; registration and marketing authorisation; pharmacovigilance; market surveillance and control; licensing of establishments; regulatory inspection; laboratory testing; and batch release of biological products. These functions are supported by 13 indicator areas and 235 sub-indicators.
Yes. Pilot feedback highlights the importance of involving the right people across relevant functions and having enough internal coordination to gather evidence, review findings and agree priorities. Feedback also points to the value of engaging senior leadership in reviewing the outcomes.
VMRA-SAT assesses the regulatory functions that support responsible oversight of veterinary antimicrobials, including registration and marketing authorisation (are antimicrobials properly evaluated before reaching the market), pharmacovigilance (are adverse effects and resistance patterns monitored), market surveillance (are products on the market what they claim to be) and inspection and supply chain controls. This gives authorities evidence to target improvements that support National Action Plans on AMR and wider One Health priorities.
The assessment produces a detailed maturity profile across all eight functions, identifying strengths and areas for improvement. Countries are encouraged to use this to develop an Institutional Development Plan (IDP) that prioritises actions, sets timelines and supports resource mobilisation. The tool can be repeated periodically to track progress.
Yes. VMRA-SAT has been piloted in 11 countries across four WOAH regions so far, selected to reflect diversity in geography, income level and regulatory maturity. Pilot countries have included Rwanda, Botswana, Kenya, Tanzania, Uganda, Zambia, Mexico, Chile, Australia, Thailand and the United Kingdom.
Across the pilot evidence, the most common challenges are the time and effort required to complete the exercise, the human resources needed, the burden of gathering and organising evidence, and the need for clearer interpretation of some indicators and more consistent application of scoring.
The Full Version (Desktop) tool can require a significant investment of time, staff and supporting evidence, as highlighted during piloting. However, this reflects the depth and value of the assessment. It provides authorities with a comprehensive and evidence-based understanding of their regulatory system, helping them identify strengths and gaps, prioritise improvements, support resource planning and monitor progress over time. For authorities that are not yet ready to undertake the full assessment because of staffing, time, resource or documentation constraints, the Lite Web Version (WebApp) provides a practical starting point.
Users value preparation, training and clear guidance on scoring, evidence and interpretation. Support materials now include the desktop user manual and assessment manual, the WebApp user manual, linked fact sheets, website guidance and training resources. Follow-up support remains useful after workshops or introductory sessions, particularly when authorities are interpreting findings and developing institutional development plan actions.
Yes. Pilot feedback has been used to refine the approach, improve support materials and develop the Lite Web Version (WebApp). The lite web version provides a streamlined entry point using simple “Yes” or “No” questions derived from the VMRA-SAT framework, while the full version (desktop) remains the comprehensive evidence-based assessment tool.
No. VMRA-SAT is intended to complement existing WOAH support mechanisms, with a specific focus on strengthening veterinary medicines regulation.
The PVS Pathway evaluates the broad performance of a country’s Veterinary Services across their functions. VMRA-SAT focuses specifically on the regulation of veterinary medicinal products, providing a detailed function-level diagnostic for veterinary medicines regulation. It is therefore complementary to, rather than duplicative of, the PVS Pathway and the Veterinary Legislation Support Programme.
Adoption would mean that VMRA-SAT is housed within WOAH as a recognised tool for supporting veterinary medicines regulatory capacity-building. This would give the tool a credible institutional home, align it with WOAH’s existing work on PVS, AMR, One Health and veterinary legislation, support sustainability, version control and technical updates, and help Member Countries and partners use a common framework and language for veterinary medicines regulatory system strengthening. Its use would remain voluntary.
VMRA-SAT can be described as a mirror for regulators, helping them reflect on what is working well, where the gaps are and what progress is needed over time. It supports veterinary medicines regulatory authorities to reflect, plan and strengthen their systems in a structured and practical way.
WOAH and its partners are currently engaging with Members and other stakeholders to gather feedback on the relevance and value of VMRA-SAT. Subject to the outcome of these consultations and the relevant governance processes, consideration of the potential adoption of VMRA-SAT will take place at the 94th WOAH General Session in May 2027.
VMRA-SAT was introduced to WOAH Delegates through a side event and exhibition kiosk at the 93rd WOAH General Session in May 2026. Additional stakeholder engagement, regional workshops, Member consultations and refinement of the tool are planned throughout 2026 and 2027.
Countries interested in using VMRA-SAT can either request access to the Full Version (Desktop) or use the Lite Web Version (WebApp) as a streamlined entry point. Countries may also request further information, a demonstration or discussion with the project team by contacting info@vmra-sat.org. There is no cost to participate as a pilot country.
The development of VMRA-SAT began through a Gates Foundation-funded project led by the UK Veterinary Medicines Directorate. GALVmed now leads the Better Regulation Project supporting further development and piloting, while WOAH facilitates global engagement and alignment with its international frameworks.
Visit the VMRA-SAT website at www.vmra-sat.org or contact the project team at info@vmra-sat.org.